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Indian patent granted
INHALED AD-214 PRECLINICAL PROGRAM PROGRESSING
Key points:
• Comprehensive package of in vivo and in vitro studies underway for AD-214 in
an inhaled format
• Aiming to confirm AD-214 can be delivered to the far airways of the lungs; be
retained in fibrotic tissues; and modulate the progression of fibrosis
• Results expected across next two quarters
• Program on track to be completed in the September quarter of 2022, despite the
data readout from an initial study being delayed due to technical difficulties
• Expert team of inhalation therapeutic advisers and contractors assisting
2 March 2022
ASX Announcement
AdAlta granted Chinese patent protecting AD-214
MELBOURNE Australia, 3 February 2022: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform, is pleased to announce that its first Chinese patent relating to lead program, AD-214, has been granted by the China National Intellectual Property Administration.
Patent Number CN 107427574 B, entitled “CXCR4 binding molecules”, has an expiry date of 8 January 2036.
The new patent protects the i-body sequence used in AdAlta’s lead product, AD-214, sequences similar to this, and pharmaceutical compositions and derivatives containing these i-body sequences. The patent also protects the use of these sequences in therapeutic and diagnostic applications, including Idiopathic Pulmonary Fibrosis (IPF), the lead indication for which AD-214 is being developed.
Patents are granted on a country-by-country basis, and China is the fifth country to grant patent protection under this application, following Australia (two patents), US (two patents), Japan and Singapore. Claims are being pursued in other major markets including the European Union and India.
AdAlta’s CEO and Managing Director, Dr Tim Oldham said:
“China is now the second largest (and fastest growing) pharmaceutical market in the world (after the US),1,2 representing 11%3 of the global prescription drug market. IPF is included in the Chinese Rare Diseases List, including it as part of China’s plan to increase availability of drugs for rare diseases.4 Patent protection for AD-214 in this important market is anticipated to further increase the already significant interest from potential China partners.”
Didn’t know this would be released this morning, but it does give some further information and updates to yesterday’s Bull case.
QUARTERLY CASH FLOW STATEMENT – DECEMBER QUARTER 2021
Quarter highlights
• Strengthened $9.08 million cash position as at 31 December 2021 ($6.77 million as at 30 September 2021)
• AD-214 shown to be stable following nebulisation in pre-clinical and commercial devices; simulated to achieve better than expected distribution to lungs
• Pre-clinical efficacy studies of AD-214 by inhalation commenced – successful results in the March 2022 quarter may accelerate partnering discussions
• Three additional patents protecting AD-214 granted
• Proof of principle iCAR-T data reported; research plan agreed for first target in
Carina collaboration
• $3.75 million raised via private Placement with existing and new institutional and sophisticated investors; Entitlement Offer closes 31 January 2022
• $0.89 million received as net proceeds of FY2021 R&D Tax Incentive rebate following repayment of Radium loan facility.
This is my first real crack at making a case for a company and this is a Biotech in early clinical stage so pleas hang in there. I would like to state at the outset that I do hold a small position, have added recently and put in for extra in the capital raising that closes 31 Jan, if I get all of the extras I hope to get then it will be 4% of my PF and no longer so small.
The Bull case:
Adalta have a novel therapy for fibrosis and it’s possible it will be extended to cancers, it’s called i-body. The current treatments for various forms of fibrosis leave a lot to be desired and the TAM is in the billions. Companies like Roche have drugs in this area. It’s big money.
In an earlier straw I mentioned the drop in SP due to a clinical trial that didn’t go so well, the active was cleared too fast by the liver in trial patients. I’m actually quite unperturbed by that as they will start trials for the lung fibrosis treatment by inhalation. Technology for this is well known and widely accepted and an inhaler has to be better for patients than yet another needle. The trials will be clinical phase 2.
They presented at Hidden Gems on Friday, the future is bright and yes we all know companies looking for shareholders and businesses partners will sing a siren song.
The Capital Raising gives me even more confidence in management. All bar one director will take up their full allocation and will take up any unsold shares. The director that isn’t taking up the entire allocation recently sold some, so that’s ok.
Management deliver, they hit their targets, they update and appear to be reliable . 2021 saw Adalta move into clinical stage for the first time. They have flagged a strong flow of reporting from their pipeline from now until 2023. They have set up trials with researchers in UK and China where the facilities are superior. They are also seeking Asian investors as Idiopathic Pulmonary Fibrosis (IPF) (a US 3 billion market and Interstitial Lung Diseases affect the Asian population at a higher rate than western populations.
If you want to know more about the technology and their research I would suggest their website. https://adalta.com.au/
The SP is sitting at 0.08c, cap raise is 0.073 and Pitt Street Estimates have a valuation of 0.27c
Adalta sp had plummeted recently after one of their product developments for lung fibrosis failed early tested due to the active ingredient being cleared too fast by the liver.
Further research has been done with an inhaled version and is showing far higher levels of the active hitting the airways than expected. Trials are running in Shanghai in mouse models with results expected very early 2022.
Yes, early biotech is a risky investment so I only have a small holding, but if Adalta are able to deliver a treatment for fibrosis they will save many lives and improve patient outcomes. Adalta hit their milestones and I trust management.
AGM. Adalta is continuing to hit their targets with one exception which needed a new drug delivery model.
Highlights of the presentations include:
• Progress report against 2021 milestones set at the 2020 AGM
• Milestones for 2022 calendar year
• Proof of principle data showing i-bodies can be incorporated into Carina’s CAR-T
cells and achieve targeted cell killing.
BTB FUNDING AGREEMENT TRANSFERRED TO AD-214 INHALED PROGRAM Key points
• AdAlta was awarded A$1 million in funding from the Medical Research Future Fund’s (MRFF) Biomedical Translation Bridge (BTB) program in December 2019
• Initial funding (A$0.22 million) was used to develop a radiolabelled version of AD-214, AdAlta’s lead asset, for PET imaging to optimise clinical development
• Insights from use of the radiolabelled product led AdAlta to alter AD-214 clinical program; much of the original grant funding was allocated to activities now no longer needed
• AdAlta and MTPConnect (who deliver the BTB program) have agreed to reallocate A$0.76 million in unspent grant funds to developing an inhaled version of AD-214 while also improving the intravenous formulation
NEW PRECLINICAL DATA PRESENTED AT “DISCOVERY ON TARGET” MEETING Key points
• Prof Mick Foley, CSO, presenting at Discovery on Target meeting, Boston
• New pre-clinical data on AD-214 in kidney fibrosis
• AD-214 pre-clinical and clinical development summarised
MELBOURNE Australia, 27 September 2021: AdAlta Limited (ASX:1AD), the clinical stage biotechnology company developing novel therapeutic products from its i-body platform advises that Chief Scientific Officer, Professor Mick Foley, is presenting virtually at the 19th Annual Discovery on Target conference being hosted in Boston from 27-30 September 2021.
Professor Foley’s presentation, “CXCR4 antagonist AD-214 as a therapy for Interstitial Lung Disease” includes new preclinical data showing potential efficacy of AD-214 in a mouse model of kidney fibrosis. It also provides a summary of the development of AD-214, including the previously reported safety, pharmacokinetic and biomarker data from the recently completed Phase I studies of AD-214, and the Company’s plans to progress an inhaled version into Phase II studies for Idiopathic Pulmonary Fibrosis (IPF).
The new pre-clinical data shows potential efficacy of AD-214 in a mouse model of kidney fibrosis known as the Unilateral Ureteral Obstruction (UUO) model. In this model, one ureter is blocked in each mouse (the other serves as a control), inducing inflammation and fibrosis and increasing levels of collagen in the obstructed kidney.
Studies conducted in collaboration with Professor Carol Pollock at the University of New South Wales showed that treatment with AD-214 by intraperitoneal administration resulted in a statistically significant reduction in the level of collagen and fibrosis in the UUO obstructed kidney compared with both no treatment and treatment with a non- CXCR4 specific control i-body. Illustrative results are shown in the figure below.
This finding is consistent with previously reported studies of AD-114 (the anti-CXCR4 i-body incorporated in AD-214) in a different model of kidney fibrosis (the Folic Acid model). Full results have been submitted for publication.
Discovery on Target is the pharmaceutical industry’s preeminent event on novel drug targets and technologies for drug discovery professionals, highlighting advances in current and emerging “hot” targets and technologies as well as target validation strategies for the discovery and development of novel therapeutic agents.
Professor Foley’s presentation forms part of a session focussed on targeting G-protein coupled receptors (GPCRs), a critically important target class for the pharmaceutical industry and is attached to this announcement.
21 September 2021
Link to the company presentation http://1ad.live.irmau.com/irm/PDF/004f19da-5501-4018-888f-0f4fde2b81a7/CorporateoverviewandIRDInvest2021presentation
ASX Announcement
CORPORATE OVERVIEW AND IRD INVEST 2021 PRESENTATION
MELBOURNE Australia, 21 September 2021: AdAlta Limited (ASX:1AD), the clinical stage drug discovery company developing novel therapeutic products from its i-body platform, is pleased to announce Dr Tim Oldham, CEO and Managing Director will present highlights from the Company’s newest corporate overview at IR Department’s, IRD Invest 2021 virtual investor conference Thursday September 23, 2021, 12.00 PM AEST (Sydney time).
The conference takes place on Wednesday 22 and Thursday 23 September, with the overarching theme “Addressing the need for change”. In keeping with the theme, day two will focus specifically on addressing new needs in patient care.
Dr Oldham’s presentation will draw on a newly revised corporate overview (which is attached), and will provide an update on AdAlta’s contribution to the conference theme, highlighting:
• The power of the i-body technology as a drug discovery platform to address diseases that have challenged traditional antibodies;
• The potential and progress of lead asset AD-214 as a new option for the degenerative and fatal disease Idiopathic Pulmonary Fibrosis;
• The use of i-body enabled PET imaging agents to identify early the responders to cancer immunotherapies; and
• The potential of i-body enabled CAR-T cells to overcome the challenges posed by solid tumours.
IRD Invest is free to attend and investors are invited to register ahead of time by CLICKING THIS LINK. You will receive a confirmation email with instructions on how to access the briefing once you have completed the registration form.
A recorded copy of AdAlta’s presentation will be made available after the event.
A$4.0 MILLION NON-DILUTIVE FINANCE FACILITY AGREEMENT WITH VICTORIAN GOVERNMENT
Key points:
• AdAlta granted A$4.0m non-dilutive R&D Rebate funding Facility with Invest Victoria. • Facility is one of the first of its kind from Victorian Government.
• Facility relates to FY2022 R&D and is in addition to existing Radium facility and
anticipated R&D incentive rebates for the FY2021 period
• Enables AdAlta to achieve near-term development milestones.
AdAlta and Carina Biotech to develop next-generation CAR-T cancer therapeutics.
There will be a webinar tomorrow for anyone interested. The link is in the attachment.
AdAlta Limited (ASX:1AD) and Carina Biotech Pty Ltd have entered a collaboration agreement to develop next-generation i-body enabled CAR-T cells, with the potential to bring CAR-T cell therapy to treat a far greater range of cancers than the small number of blood cancers that has been achieved today.
CAR-T cell therapy is a fast-emerging form of cancer therapy that modifies a patient's immune system to recognise and attack cancer cells that have resisted standard treatments such as chemotherapy and radiation.
I must admit to being a fan of Adalta, they started clinical trials for the first time this year and even though it is very early they are working in an important area and have a collaboration with GE Healthcare.
They would appear to be well managed, they stick to timelines, their Executive team is highly experienced and even though their price sharply fell recently (see my previous straw) they are already rebounding.
Their target market is extensive and would be lucrative if they can break through. They received orphan drug status in the US FDA which gives them access and reduced costs.
Their recent stage 1 trials for lung fibrosis showed the drug was processed too rapidly by the liver so they are planning to move to an inhaler format. For patients this is no issue as they are used to inhalers.
Even though the end point was not going to be delayed the market saw a major sell down. This appears to have stabilised and purchases are on the way back up.
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